Subchondroplasty Procedure in Patients With Bone Marrow Lesions

Inclusion Criteria: * At least 18 years of age at time of screening * Patient with BML(s) in one or both knees, as diagnosed by the treating physician, willing and eligible to undergo the SCP Procedure * One or more BML(s) of the tibial plateau and/or femoral condyle extending to the articular surface of the joint confirmed on T2 weighted fat-suppressed or fat-suppressed Proton Density MR Imaging by presence of white signal * Patient's index knee alignment, which is defined radiographically, must be one of the following: Neutral, 6 degree mechanical varus, or 6 degree mechanical valgus * Patient is refractory to conservative non-surgical management of BML: * Having failed 2 or more of the following: hyaluronic acid (HA) injection, corticosteroid injection, non-steroidal anti-inflammatory drugs (NSAIDs), physical therapy, bracing, or minimal surgical intervention (e.g. arthroscopy, debridement/chondroplasty, and/or loose body removal) * and diagnosis of BML is more than 3 months of the study treatment * Willing and able to comply with the study procedures * Signed an informed consent form approved by independent ethics committee (IEC) Exclusion Criteria: * Existing acute or chronic infections at the surgical site * Bone in the index knee is non-viable or not capable of supporting and anchoring the implant. * Known systemic disorders or any systemic inflammatory condition (e.g. rheumatoid arthritis) * Acute traumatic injuries with open wounds close to the bone defect which are likely to become infected * Known metabolic bone disease, including disorders in calcium metabolism * Known immunologic abnormalities, including inflammatory bone disease * Has a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for 5 years * Diagnosis of patella-femoral joint OA and/or primarily patella-femoral symptoms * BML caused by acute trauma less than 3 months prior to enrollment * Clinical and/or radiographic disease diagnosis of the index knee that includes any of the following: * Kellgren-Lawrence grade 4 Osteoarthritis (OA) * BML located at anterior cruciate ligament (ACL)/ posterior cruciate ligament (PCL) insertion * Any major or cartilage repair or alignment surgery (i.e. osteotomy, autograft, scaffold, marrow stimulation, debridement, all cell-based therapies, etc.) of the index knee within 12 months prior to enrollment * Pregnant at time of injection * Lactating at time of injection * Use of any investigational drug or device within 30 days prior to enrollment * Use of any investigational biologics within 30 days prior to enrollment